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Last Updated: March 3, 2024

Regulatory Exclusivity Expiring in 2022


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Drugs with Regulatory Exclusivity Expiring in 2022

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Redhill TALICIA amoxicillin; omeprazole magnesium; rifabutin CAPSULE, DELAYED RELEASE;ORAL 213004-001 Nov 1, 2019 RX Yes Yes ⤷  Try a Trial NEW PRODUCT
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Try a Trial NEW CHEMICAL ENTITY
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes ⤷  Try a Trial NEW CHEMICAL ENTITY
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes ⤷  Try a Trial NEW CHEMICAL ENTITY
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes ⤷  Try a Trial NEW CHEMICAL ENTITY
Astellas CRESEMBA isavuconazonium sulfate CAPSULE;ORAL 207500-002 Nov 22, 2022 RX Yes No ⤷  Try a Trial FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Astellas CRESEMBA isavuconazonium sulfate CAPSULE;ORAL 207500-001 Mar 6, 2015 RX Yes Yes ⤷  Try a Trial TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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